510(k) · Cleared
ClearedUnison-C Anterior Cervical Fixation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · OVE Intervertebral Fusion Device With Integrated Fixation, Cervical
Cleared on Jan 19, 2016 as substantially equivalent to K121151 (Life Spine, Inc., 2012) and 5 other predicates after a 113-day review. Its family tree reaches back 14 generations to 1984. 29 later devices descend from it.
- Decided
- Jan 19, 2016
- Review
- 113 days
- Class
- Class II
- Product code
- OVE
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 14 generations to K841189 (1984). 144 ancestors in all, the oldest K792352 (1979). 29 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 10 generations between
- 3 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
- 2 generations backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
- 1 generation backK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
- This deviceK152793 Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
- Descendant · cites it directly · 25 of its ownK200087 F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020
- Descendant · 2 generations on · 18 of its ownK212853 Cervical Stand-Alone SystemEminent Spine, LLC · 2021
- Descendant · 3 generations on · 5 of its ownK223105 Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022
- Descendant · 3 generations on · 5 of its ownK223190 Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022
- Descendant · cites it directly · 5 of its ownK170830 Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2017
Show all 14 generations
- Root · 14 generations backK841189 Oec/Rezaian Spinal FixatorOrthopedic Equipment Co., Inc. · 1984
- 13 generations backK990148 Stackable Cage SystemDepuy Motech Acromed · 1999
- 12 generations backK003043 Surgical Titanium Mesh SystemDepuyacromed · 2001
- 11 generations backK022793 Tetris Spinal ImplantSignus Medical, LLC · 2003
- 10 generations backK031757 Peek Tetris Spinal ImplantSignus Medical, LLC · 2003
- 9 generations backK041888 Curved Peek Tetris Spinal ImplantSignus Medizintechnik GmbH · 2004
- 8 generations backK042930 Spacevision Cage SystemSpine Vision, Inc. · 2004
- 7 generations backK062759 Paramount VBR SystemInnovative Spinal Technologies, Inc. · 2007
- 6 generations backK072120 Paramount Intervertebral Body Fusion DeviceInnovative Spinal Technologies, Inc. · 2007
- 5 generations backK080401 Shell Cage, Wave Cage, Loop CageAdvanced Medical Technologies AG · 2008
- 4 generations backK082801 Phantom Plus Cage SystemUs Spine · 2008
- 3 generations backK093093 Small Plateau Spacer SystemLife Spine · 2010
- 2 generations backK111835 Plateau Spacer SystemLife Spine, Inc. · 2011
- 1 generation backK121151 Pro-Link Cervical Spacer SystemLife Spine, Inc. · 2012
- This deviceK152793 Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2016
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K200087F3D Cervical Stand-Alone Interbody Fusion SystemCorelink, LLC · 2020 · cites it directly25descendants
- K212853Cervical Stand-Alone SystemEminent Spine, LLC · 2021 · 2 generations on18descendants
- K223105Tesera-K SC SystemKyocera Medical Technologies, Inc. · 2022 · 3 generations on5descendants
- K223190Hive™ Standalone Cervical SystemNanoHive Medical, LLC · 2022 · 3 generations on5descendants
- K170830Unison-C Anterior Cervical Fixation SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. · 2017 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K841189 | Oec/Rezaian Spinal Fixator | Orthopedic Equipment Co., Inc. | 1984 | — |
| −13 | K990148 | Stackable Cage System | Depuy Motech Acromed | 1999 | — |
| −12 | K003043 | Surgical Titanium Mesh System | Depuyacromed | 2001 | — |
| −11 | K022793 | Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −10 | K031757 | Peek Tetris Spinal Implant | Signus Medical, LLC | 2003 | — |
| −9 | K041888 | Curved Peek Tetris Spinal Implant | Signus Medizintechnik GmbH | 2004 | — |
| −8 | K042930 | Spacevision Cage System | Spine Vision, Inc. | 2004 | — |
| −7 | K062759 | Paramount VBR System | Innovative Spinal Technologies, Inc. | 2007 | — |
| −6 | K072120 | Paramount Intervertebral Body Fusion Device | Innovative Spinal Technologies, Inc. | 2007 | — |
| −5 | K080401 | Shell Cage, Wave Cage, Loop Cage | Advanced Medical Technologies AG | 2008 | — |
| −4 | K082801 | Phantom Plus Cage System | Us Spine | 2008 | — |
| −3 | K093093 | Small Plateau Spacer System | Life Spine | 2010 | — |
| −2 | K111835 | Plateau Spacer System | Life Spine, Inc. | 2011 | — |
| −1 | K121151 | Pro-Link Cervical Spacer System | Life Spine, Inc. | 2012 | — |
| 0 (this device) | K152793 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2016 | — |
| +1 | K200087 | F3D Cervical Stand-Alone Interbody Fusion System | Corelink, LLC | 2020 | — |
| +2 | K212853 | Cervical Stand-Alone System | Eminent Spine, LLC | 2021 | — |
| +3 | K223105 | Tesera-K SC System | Kyocera Medical Technologies, Inc. | 2022 | — |
| +3 | K223190 | Hive™ Standalone Cervical System | NanoHive Medical, LLC | 2022 | — |
| +1 | K170830 | Unison-C Anterior Cervical Fixation System | Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1980 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1996 | 6 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 12 | 0 |
| 2002 | 10 | 0 |
| 2003 | 13 | 0 |
| 2004 | 18 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 9 | 0 |
| 2008 | 19 | 0 |
| 2009 | 10 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 4 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 7 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OVE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVE device
- #1 K241846 E3D™-C Interbody Systemscore 32.1 · 32 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (6)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K121151 | Pro-Link Cervical Spacer SystemSummary page 5…e Principle of operation Table 5-1 Predicate Devices 510k Number Trade or Proprietary or Model Name Manufacturer Predicate Type K121151 Pro-Link Cervical Spacer Link Spine Primary K142079 STALIF C®… | 2012 |
| * | K142079 | Stalif Cti, Stalif CSummary page 5…Proprietary or Model Name Manufacturer Predicate Type K121151 Pro-Link Cervical Spacer Link Spine Primary K142079 STALIF C® Centinel Spine, Inc. Additional K113796 Solitaire®-C Cervi… | 2014 |
| * | K113796 | Solitaire-C Cervical Spacer SystemSummary page 5…ink Cervical Spacer Link Spine Primary K142079 STALIF C® Centinel Spine, Inc. Additional K113796 Solitaire®-C Cervical Spacer System Biomet Spine Additional K113559 Cervical Interbody… | 2012 |
| * | K113559 | LDR Spine Cervical Interbody Fusion Systme-Roi-C Lordotic ImplantsSummary page 5…® Centinel Spine, Inc. Additional K113796 Solitaire®-C Cervical Spacer System Biomet Spine Additional K113559 Cervical Interbody Fusion System ROI-C LDR Spine USA Additional K102606 AVS® Anchor-C Cerv… | 2011 |
| * | K102606 | Avs Anchor-C Cervical Cage SystemSummary page 5…e®-C Cervical Spacer System Biomet Spine Additional K113559 Cervical Interbody Fusion System ROI-C LDR Spine USA Additional K102606 AVS® Anchor-C Cervical Cage System Stryker Spine Additional K142218 COALITION AGX… | 2011 |
| * | K142218 | Coalition AGX Plate and Coalition AGX SpacerSummary page 5…Interbody Fusion System ROI-C LDR Spine USA Additional K102606 AVS® Anchor-C Cervical Cage System Stryker Spine Additional K142218 COALITION AGX Globus Additional PERFORMANCE DATA The Unison-C Anterio… | 2015 |
What descends from it? (29)
See all 294 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 12 companies; a new generation was cleared every 1.3 years on median.
- 16 of the 144 ancestors have a recall of any class.
- Of its descendants, K200087 (Corelink, LLC, 2020) has gone furthest, with 25 descendants of its own.
- 4 other devices also cite its predicate K121151.
How does its category compare?
All OVE devicesOVE Intervertebral Fusion Device With Integrated Fixation, Cervical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OVE
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OVE
105in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OVE
2in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OVE
132in 2025
MAUDE reports naming product code OVE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 4 | 131 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 4 | 210 | 0 | 2 |
| 2011 | 8 | 139 | 0 | 19 |
| 2012 | 7 | 125 | 0 | 59 |
| 2013 | 5 | 71 | 1 | 250 |
| 2014 | 11 | 168 | 1 | 150 |
| 2015 | 12 | 113 | 1 | 173 |
| 2016 | 15 | 149 | 1 | 145 |
| 2017 | 9 | 100 | 1 | 134 |
| 2018 | 7 | 105 | 0 | 210 |
| 2019 | 7 | 87 | 0 | 169 |
| 2020 | 13 | 149 | 0 | 162 |
| 2021 | 10 | 93 | 2 | 186 |
| 2022 | 10 | 144 | 0 | 200 |
| 2023 | 16 | 97 | 0 | 148 |
| 2024 | 6 | 56 | 0 | 142 |
| 2025 | 10 | 105 | 0 | 132 |
| 2026 | 13 | 66 | 0 | — |
What is it indicated for?
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised…
Read the full statement (114 words)
The Unison-C Anterior Cervical Fixation System is indicated for stand-alone anterior cervical interbody fusion procedures in skeletally mature patients with degenerative disc disease (DDD) at one level from C2 to T1. DDD is defined as neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The Unison-C Anterior Cervical Fixation System is to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft and is implanted via an anterior approach. The Unison-C Anterior Cervical Fixation System must be used with two of the provided bone screws. This cervical device is to be used in patients who have had six weeks of non-operative treatment.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152793 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152793: Unison-C Anterior Cervical Fixation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152793
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026